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Test Code 227 Estradiol

Important Note

Human Anti-Mouse Antibodies (HAMA) may be present in samples from patients who have received immunotherapy or diagnostic procedures utilizing monoclonal antibodies or in individuals who have been regularly exposed to animals. Additionally, other heterophile antibodies, such as human anti-goat antibodies may be present in patient samples. Manufacturers formulate assays to minimize the effects of these antibodies; however careful evaluation of patient results must be done when patients are known to have such antibodies.

Additional Codes

ALAB: ESTR

PowerChart: Estradiol Level

MA Cerner: Estradiol

Test Method

Competitive Binding Immunoenzymatic Assay; Beckman DxC700AU, Standardized to the ID-GCMS International Reference Method

Specimen Requirement

0.5 mL serum or plasma is required.

Additional Specimen Collection Information

Collect blood in a lithium heparin, green-top or red-top tube. PST and SST (gel tubes) are acceptable. Serum or plasma should be separated from contact with the cells within 2 hours of collection. Specimens not centrifuged within 4 hours of collection may be rejected. Refrigerate the specimen if unable to assay within 8 hours of collection. If specimen are to be stored longer than 48 hours they must be stored frozen at -20 C.

Performance

Testing is performed Monday through Sunday.

Routine: Typically completed within 4 hours after the specimen arrives at the testing site.

STAT: Typically completed within 1.5 hours after the specimen arrives at the testing site.

Reference Values

Male: <20-47 pg/mL

Adult (Nonpregnant) Female:

  • Mid-follicular phase: 27-122 pg/mL
  • Periovulatory: 95-433 pg/mL
  • Mid-luteal phase: 49-291 pg/mL
  • Postmenopausal: <20-40 pg/mL

CPT Code Information

82670 Chemistry: Estradiol

Useful For

All applications that require moderately sensitive measurement of estradiol:

  • Evaluation of hypogonadism and oligo-amenorrhea in females
  • Assessing ovarian status, including follicle development, for assisted reproduction protocols (eg, in vitro fertilization)
  • In conjunction with lutenizing hormone measurements, monitoring of estrogen replacement therapy in hypogonadal premenopausal women
  • Evaluation of feminization, including gynecomastia, in males
  • Diagnosis of estrogen-producing neoplasms in males, and, to a lesser degree, females
  • As part of the diagnosis and work-up of precocious and delayed puberty in females, and, to a lesser degree, males
  • As part of the diagnosis and work-up of suspected disorders of sex steroid metabolism, eg, aromatase deficiency and 17 alpha-hydroxylase deficiency
  • As an adjunct to clinical assessment, imaging studies and bone mineral density measurement in the fracture risk assessment of postmenopausal women, and, to a lesser degree, older men
  • Monitoring low-dose female hormone replacement therapy in post-menopausal women
  • Monitoring antiestrogen therapy (eg, aromatase inhibitor therapy)

LOINC Code Information

2243-4 Estradiol (E2) [Mass/Volume] In Serum Or Plasma

Limitations

  1. Patients who have been regularly exposed to animals or have received immunotherapy or diagnostic procedures utilizing immunoglobulins or immunoglobulin fragments may produce human anti-animal antibodies, for example Human anti-mouse antibodies (HAMA), that interfere with immunoassays. Additionally, other antibodies such as human anti-goat antibodies may be present in patient samples. Manufacturers formulate assays to minimize the effects of these antibodies, however careful evaluation of patient results must be done when patients are known to have such antibodies.
  2. Other potential interfering substances include: Rheumatoid Factor, endogenous alkaline phosphatase, fibrin, and protein capable of binding alkaline phosphatase. Carefully evaluate results if the sample is suspected of having these type of interferences.
  3. The Access Sensitive Estradiol assay results are not intended to be used to measure the effectiveness of exogenous Estradiol supplementation, for example when the patient is on hormone replacement therapy. The presence of estradiol drug analogues and their metabolites could have an impact on estradiol recovery when using this assay.